Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-02 @ 4:49 AM
Study NCT ID:
NCT05163366
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2021-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Morphine Versus Ketamine in Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Rectal ketamine versus oral morphine in pain management in paediatric wound and burns'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-17', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-12-17', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAIN SCORES ON ORAL MORPHINE VERSUS KETAMINE ARM', 'timeFrame': '4 hours', 'description': 'The primary endpoint will be difference in pain scores on a Revised FLACC(Face, Leg, Activity, Cry, Consolability) scale in the two arms.The primary endpoint will be difference in pain scores on a Revised FLACC(Face, Leg, Activity, Cry, Consolability) scale in the two arms. Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0: Relaxed and comfortable, 1-3 : Mild discomfort ,4-6 : Moderate pain, 7-10 : Severe discomfort or pain or both'}, {'measure': 'DIFFERENCE IN THE INCIDENCE OF ADVERSE EFFECTS IN ORAL MORPHINE VERSUS KETAMINE ARM', 'timeFrame': '4 hours', 'description': 'Secondary endpoint will be the difference in the incidence of adverse effects a cross arms obtained from patient, nurse, and chart for DAIDS Adverse Event Grading Table 2014.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Procedural']}, 'descriptionModule': {'briefSummary': 'The study will mainly focus on procedural pain management using oral morphine versus rectal ketamine during paediatric burn and wound dressing at Mbarara Regional Referral Hospital.', 'detailedDescription': 'Subjects will be randomly assigned to one of the two treatment groups A and B. Guardians of patients who are scheduled for burn wound care will sign written consent pre- operatively about procedural pain management. Group A will receive rectal ketamine while those in Group B will receive only traditional standard of care protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients between 6 months and 6-years old scheduled for a minimum of one procedure for burn wound dressing at the pediatric unit at Mbarara Regional Referral Hospital\n\nExclusion Criteria:\n\n* Children with rectal or anal pathology,\n* Refusal to assent to participate or parental or guardian refusal to consent in the study\n* Children who require mechanical ventilation or already intubated in Intensive care unit\n* Those allergic to Ketamine or its constituents'}, 'identificationModule': {'nctId': 'NCT05163366', 'briefTitle': 'Oral Morphine Versus Ketamine in Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Mbarara University of Science and Technology'}, 'officialTitle': 'Oral Morphine Versus Rectal Ketamine in Pain Management During Burns Wound Dressing Changes in Paediatric Population at Mbarara Regional Referral Hospital: An Open Label Randomized Trial', 'orgStudyIdInfo': {'id': '2021/ANDREW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP A', 'description': 'Group A will receive rectal ketamine(Ket)', 'interventionNames': ['Drug: GROUP A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP B', 'description': 'Group B will receive only traditional standard of care protocols.', 'interventionNames': ['Drug: GROUP B']}], 'interventions': [{'name': 'GROUP A', 'type': 'DRUG', 'otherNames': ['KETAMINE GROUP'], 'description': "Rectal Ketamine will be administered at 6 mg/kg and with a rectal nozzle it's infused through the rectum. The rectal ketamine will be administered after scoring pain just before the start of the procedure and then about 15 minutes later the procedure will start when the patient has achieved a nystagmus.", 'armGroupLabels': ['GROUP A']}, {'name': 'GROUP B', 'type': 'DRUG', 'otherNames': ['MORPHINE GROUP'], 'description': 'The tradition standard protocols involve the use of 0.3mg/kg of oral morphine about an hour before the start of the procedure before the start of the procedure to allow for the onset of action of oral morphine for every single procedure in this arm.', 'armGroupLabels': ['GROUP B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00256', 'city': 'Mbarara', 'country': 'Uganda', 'facility': 'Mbarara Regional Referral Hospital', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}, {'zip': '256', 'city': 'Mbarara', 'country': 'Uganda', 'facility': 'Mbarara Regional Referral Hospital', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'overallOfficials': [{'name': 'ALICE G. ATAI, MbChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mbarara University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mbarara University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}